Escalation of adjuvant endocrine therapy for early hormone-dependent HER2-negative breast cancer: to whom, when and why?

Cover Page

Cite item

Full Text

Abstract

This review presents the evolution of adjuvant endocrine therapy for early hormone-dependent HER2-negative breast cancer, describes late relapse phenomenon, provides clinical rationale for escalation of treatment, analyzes the key stages of the metastatic cascade, and provides a scientific rationale for the introduction of CDK4/6 inhibitors into adjuvant treatment regimens. The main results of two large randomized studies of therapy including abemaciclib (MonarchE) and ribociclib (NATALEE) in patients with early stages of hormone-dependent HER2-negative breast cancer are presented; the oncological results of escalation of treatment and the safety of therapy are assessed.

About the authors

I. V. Kolyadina

Russian Medical Academy of Continuous Professional Education, Ministry of Health of Russia;
V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Author for correspondence.
Email: irinakolyadina@yandex.com
ORCID iD: 0000-0002-1124-6802

Irina Vladimirovna Kolyadina  

2/1 Barrikadnaya St., Moscow 125993, Russia;

4 Akademika Oparina St., Moscow 117198, Russia 

Russian Federation

References

  1. Schiavon G., Smith I. Status of adjuvant endocrine therapy for breast. Breast Cancer Res 2014;16(2):206. Available at: http://breast-cancer-research.com/content/16/2/206. doi: 10.1186/bcr3636
  2. Love R.R., Philips J. Oophorectomy for breast cancer: History revisited. J Natl Cancer Inst 2002;94:1433–4. doi: 10.1093/jnci/94.19.1433
  3. Early Breast Cancer Trialists’ Collaborative Group: Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer. An overview of 61 randomized trials among 28,896 women. N Engl J Med 1988;319:1681–92. doi: 10.1056/NEJM198812293192601
  4. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687–717. doi: 10.1016/S0140-6736(05)66544-0
  5. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: Patient-level meta-analysis of randomised trials. Lancet 2011;378(9793):771–84. doi: 10.1016/S0140-6736(11)60993-8
  6. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: Patient-level meta-analysis of the randomised trials. Lancet 2015;386:1341–52. doi: 10.1016/S0140-6736(15)61074-1
  7. Pagani O., Francis P.A., Fleming G.F. et al. Absolute improvements in freedom from distant recurrence to tailor adjuvant endocrine therapies for premenopausal women: Results from TEXT and SOFT. J Clin Oncol 2020;38(12):1293–303. doi: 10.1200/JCO.18.01967
  8. Kim H.A., Lee J.W., Nam S.J. et al. Adding ovarian suppression to tamoxifen for premenopausal breast cancer: A randomized phase III trial. J Clin Oncol 202038(5):434–43. doi: 10.1200/JCO.19.00126
  9. Baek S., Woo Chul N., Sei-Hyun A. et al. Adding ovarian function suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or resume menstruation after chemotherapy: 8-year follow-up of the randomized ASTRRA trial. J Clin Oncol 2023;41(31):4864–71. doi: 10.1200/JCO.23.00557
  10. Tyulyandin S.A., Artamonova E.V., Zhigulev A.N. et al. Practical recommendations for drug treatment of breast cancer. Zlokachestvennye opukholi: Prakticheskie rekomendatsii RUSSCO = Malignant tumors: Practical recommendations RUSSCO 2023;13:157–200. (In Russ.).
  11. Pan H., Gray R., Braybrooke J. et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017;377:1836–46. doi: 10.1056/NEJMoa1701830
  12. Davies C., Pan H., Godwin J. et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet 2013;381(9869):805–16. doi: 10.1016/S0140-6736(12)61963-1
  13. Rea D.W., Gray R.G., Bowden S.J. et al. Overall and subgroup findings of the aTTom trial: A randomized comparison of continuing adjuvant tamoxifen to 10 years compared to stopping after 5 years in 6953 women with ER positive or ER untested early breast cancer. Eur J Cancer 2013;49:S298–S449.
  14. Clement Z., Kollias J., Bingham J. et al. Extended duration of adjuvant aromatase inhibitor in breast cancer: A meta-analysis of randomized controlled trials. Gland Surg 2018;7(5):449–57. doi: 10.21037/gs.2018.08.03
  15. Gray R., Early Breast Cancer Trialists’ Collaborative Group. Effects of prolonging adjuvant aromatase inhibitor therapy beyond five years on recurrence and cause-specific mortality: An EBCTCG meta-analysis of individual patient data from 12 randomised trials including 24,912 women. Cancer Res 2019;79(4 Suppl):GS3-03.
  16. Beckwitt C. Breast cancer metastatic dormancy and emergence, a role for adjuvant statin therapy. University of Pittsburgh, 2018.
  17. Slamon D. Rationale and trial design of NATALEE: A phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer. Ther Adv Med Oncol 2023;15:1–16. DOI: 10.1177/ 17588359231178125
  18. Jacobson A. Ribociclib improves overall survival in HR+/HER2–metastatic breast cancer across common genomic and clinical subtypes. Oncologist 2022;27(Suppl 1):S11, S12. doi: 10.1093/oncolo/oyac010
  19. Takahashi N., Shimizu C., Shimomura A., Toi M. Role of abemaciclib in primary breast cancer: A narrative review of MonarchE. Transl Breast Cancer Res 2022;3:3.
  20. Slamon D., Diéras V., Rugo H.S. et al. Overall survival with palbociclib plus letrozole in advanced breast cancer. J Clin Oncol 2024;42(9):994–1000. doi: 10.1200/JCO.23.00137
  21. Yamamoto-Ibusuki M., Arnedos M., André F. Targeted therapies for ER+/HER2– metastatic breast cancer. BMC Med 2015;13:137. doi: 10.1186/s12916-015-0369-5
  22. Herbig U., Ferreira M., Condel L. et al. Cellular senescence in aging primates. Science 2006;311(5765):1257. doi: 10.1126/science.1122446
  23. Torres-Guzmán R., Calsina B., Hermoso A. et al. Preclinical characterization of abemaciclib in hormone receptor positive breast cancer. Oncotarget 2017;8:69493–507. doi: 10.18632/oncotarget.17778
  24. Mamedov M. to the 25th anniversary of the discovery of telomerase. Replicative cell aging: Results of half a century of study. Biomeditsina = Biomedicine 2010;(3):34–8. (In Russ.).
  25. Kovatcheva M., Liu D., Dickson M. et al. MDM2 turnover and expression of ATRX determine the choice between quiescence and senescence in response to CDK4 inhibition. Oncotarget 2015;6(10):8226–43. doi: 10.18632/oncotarget.3364
  26. Faget D.V., Ren Q., Stewart S. Unmasking senescence: Contextdependent effects of SASP in cancer. Nat Rev Cancer 2019;19:439–53. doi: 10.1038/s41568-019-0156-2
  27. Petroni G., Formenti S., Chen-Kiang S., Galluzzi L. Immunomodulation by anticancer cell cycle inhibitors. Nat Rev Immunol 2020;20:669–79. doi: 10.1038/s41577-020-0300-y
  28. Zhang J., Bu X., Wang H. et al. Cyclin D-CDK4 kinase destabilizes PD-L1 via cullin 3-SPOP to control cancer immune surveillance. Nature 2018;553:91–5. doi: 10.1038/NATURE25015.
  29. Laphanuwat P., Jirawatnotai S. Immunomodulatory roles of cell cycle regulators. Front Cell Dev Biol 2019;7. doi: 10.3389/FCELL.2019.00023
  30. Chaikovsky A.C., Sage J. Beyond the cell cycle: Enhancing the immune surveillance of tumors via CDK4/6 inhibition. Mol Cancer Res 2018;16:1454–7. doi: 10.1158/1541-7786.MCR-18-0201
  31. Johnston S., Harbeck N., Hegg R. et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (MonarchE). J Clin Oncol 2020;38(34):3987–98. doi: 10.1200/JCO.20.02514
  32. Toi M., Boyle F., Im Y.H. et al. Adjuvant abemaciclib combined with endocrine therapy (ET): Efficacy results in MonarchE cohort 1. Oncologist 2023;28(1):e77–e81. doi: 10.1093/oncolo/oyac234
  33. Stephen R.D., Johnston S. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, highrisk early breast cancer (MonarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol 2023;24(1):77–90. doi: 10.1016/S1470-2045(22)00694-5
  34. Rastogi P., O’Shaughnessy J., Martin M. et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: Results from a preplanned MonarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol 2024;42(9):987–93. doi: 10.1200/JCO.23.01994
  35. Hortobagyi G. Ribociclib + nonsteroidal aromatase inhibitor as adjuvant treatment in patients with HR+/HER2- early breast cancer: Final invasive disease-free survival analysis from the NATALEE trial. SABCS 2023. Abstract GS03-03.
  36. Gnant M., Dueck A.C., Frantal S. et al. Adjuvant palbociclib for early breast cancer: The PALLAS trial results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol 2021;40(3):282–93. doi: 10.1200/JCO.21.02554
  37. Loibl S., Marmé F., Martin M. et al. Palbociclib for residual highrisk invasive HR-positive and HER2-negative early breast cancer – The Penelope-B trial. J Clin Oncol 2021;39(14):1518–30. doi: 10.1200/JCO.20.03639
  38. Hortobagyi G., Stemmer S., Burris H. et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med 2022;386(10):942–50. doi: 10.1056/NEJMoa2114663
  39. Slamon D.J., Neven P., Chia S. et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: Updated overall survival. Ann Oncol 2021;32(8):1015–24. doi: 10.1016/j.annonc.2021.05.353
  40. Hurvitz S., Wheatley-Price P., Tripathy D. et al. Ribociclib (RIB) + tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2–) advanced breast cancer (ABC) who received prior chemotherapy (CT): MONALEESA-7 subgroup analysis. J Clin Oncol 2018;36(15 Suppl). doi: 10.1200/JCO.2018.36.15_suppl.10
  41. El Saghir N.S., Sim Yap Y., Eralp Y. et al. Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2-advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial. J Clin Oncol 2023;41(16 Suppl). doi: 10.1200/JCO.2023.41.16_suppl.106

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c)


СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 36991 от  21.07.2009.